This invention relates to devices for atraumatic intra operative dilatation of an intestine, and more particularly to such devices which include means for dilating each end of the resected intestine segment prior to anastomosis.
At present, a gastro-intestinal operation may include a resection (cutting a segment of intestine apart), with subsequent anastomosis (suturing of the intestine segments).
Suturing may be performed by hand suturing or, in a preferred method, by stapling using a specially devised instrument.
The anastomosis instrument now in use is a circular stapling device, including means for bringing the intestine ends close to each other and in a relative orientation suitable for suturing, and means for applying a plurality of staples to attach the intestine ends to each other, so as to achieve the desired arastomosis.
A problem with the above method is the natural tendency of intestine ends to shrink after being cut apart. That is, after resection both intestine ends tend to contract.
This phenomenon presents a problem to the surgeon: since the intestine has a smaller diameter, a smaller diameter anastomosis instrument has to be used, since a larger diameter instrument may be difficult to insert into the intestine. The instrument is difficult to insert, and it may be difficult to remove after suturing.
Similarly, if manual suturing or other method is used, the suturing will be applied to the small diameter (shrunk) of the intestine end.
It is well known among gastro-intestinal surgeons that a larger diameter anastomosis is preferred, since it results in better performance of the anastomosis in the long run.
However, because of intestine shrinkage, the surgeon has to accept a smaller diameter suture because of the shrunk intestine ends.
A solution to the problem is the use of rigid, metallic cylinders of various diameters, which may be forcibly introduced into the intestine to gradually dilate it.
Various devices available in prior art apparently cannot solve this problem, that is to dilate the intestine to facilitate the performance of a larger diameter anastomosis using an inflating balloon.
Thus, HILDEBRAND J., Patent DD 234228, discloses an implantable external anastomosis splint, which comprises ring of biologically inert spiral steel wire. The implantable external splint is for anastomoses, particularly those of the bile passage. It comprises an external ring of spiral biologically inert steel wire in a number of turns, the internal diameter corresponding to intraoperative requirements. It can also be in the form of a sleeve with peripheral openings.
The patent is not for a removable device, not suitable for the gastro-intestines.
DOMANSKII B. V. et al, Patent SU 1146011, discloses a method of treatment for bile duct cicatricial strictures, comprising repeatedly inflating a balloon. The method of treatment for cicatricial strictures of the bile acts involves forming a bilio-digestive anastomosis on an external drain equipped with an inflatable balloon on the catheter.
The balloon of the catheter is positioned in the lumen of the anastomosis and then once sufficient time has passed for the anastomosis to heal, under x-ray monitoring the balloon is dilated using an x-ray contrastive substance until it takes on the form of an hour glass, and then the balloon is further dilated while maintaining this form as the anastomosis is dilated over the length of the whole period of treatment.
There should be intervals of 5-6 days between the additional dilation cycles of the balloon.
In the above method, an existing anastomosis is dilated in a multi-stage treatment. The present invention, however, relates to a method for achieving a better anastomosis by dilating the intestine prior to anastomosis.
SOLAR R. J., Patent WO 9700094, discloses a method for delivering balloon-expandable stent--involves firmly positioning stent in non expanded form around balloon on distal portion of balloon dilatation catheter. The method involves firmly positioning the stent in non expanded form around the balloon on the distal portion of a balloon dilatation catheter. The distal portion of the catheter is inserted percutaneously into a patient's body to a desired site. The balloon is inflated to cause the stent to expand. The balloon is deflated, and the catheter is removed proximally from the patient's body. The balloon dilatation catheter comprises a catheter shaft defining first and second inflation lumens. Each lumen has proximal and distal ends, and an inflatable dilatation balloon having proximal and distal ends. The distal end of the first lumen opens into and is in fluid communication with the interior of the dilatation balloon. The second lumen extends longitudinally with the first lumen.
The proximal end of the second lumen is adjacent to the proximal end of the first lumen. The second lumen distal end is open and distal to the firs lumen distal end. The section of the second lumen distal to the proximal end of the dilatation balloon is exterior to the dilation balloon. The distal end of the second lumen is open and distal to the distal end of the dilatation balloon. The second lumen sufficiently linear to allow the catheter to be slidingly advanced over a guide wire.
ADVANTAGE--Provides balloon catheter which can apply a focused variable force for dilation, at lower pressures.
Birtwell, U.S. Pat. No. 3,053,257, discloses a catheter or surgical appliance that is adapted to facilitate drainage from a body cavity. It uses a balloon type catheter. The device has an inflatable portion that is adapted to retain and hold the catheter in the position of use when it is inserted into the urethra tube of the patient. The device has a different use than the present invention, and a corresponding different structure to accomplish it.
Thus, the distal end of the body in Birtwell is formed in a generally rounded configuration to allow its entry into the urethra tube.
Additional instruments may be used to hold the intestine dilated during the insertion of a catheter, however such a procedure may require more than one person to perform. There is a coordination problem and the procedure may take more time.
The above and other factors may result in a lower quality operation and may cause post-operation complications.
A very thin device could be inserted into the intestine, however that would not be useful for dilating the intestine that has a much larger diameter. The surgeon may find such a device difficult to use and to locate in the precise position in the intestine, as required.
Moreover, the distal end in Birtwell has an opening or drainage eye therein for drainage purposes, which eye communicates with a longitudinally extending passage in the catheter.
A hollow tube like that in Birtwell may enable contamination due to passage of fecal material through the tube to the operative field. Therefore, it seems that the device in Birtwell may not be suitable for atraumatic dilatation in internal surgery.
The catheter body in Birtwell is made of a flexible material such as plastic. Such a device would keep both hands of a surgeon occupied to operate it. Thus, a surgeon has to insert and hold one end of the device with one hand, while concurrently operating the air pump with the other hand.
During an operation, it is of paramount importance to free a surgeon's hand, that may then be used for other tasks.
The structure in Birtwell does not address the above issues, since it is not intended to be used in internal surgery of the intestine.
Ichilian, U.S. Pat. No. 1,235,142, discloses a syringe adapted especially for the use of women. It has a first bulb filled with air, connected to a second bulb that is normally deflated. When the first bulb is compressed, air will be forced through a neck to the second bulb to inflate it. The purpose of the inflated second bulb is to act as a closure or sealing device for the parts into which said bulb is introduced.
The first and second bulbs are mounted on a discharge tube expanding into a rounded discharge head or nozzle suitably perforated. The tube and head are made of hard rubber or similar material.
The structure in Ichilian is different than that of the present invention and serves a different purpose. Whereas in Ichilian the inflated second bulb acts as a closure or sealing device for the parts into which said bulb is introduced, in the present invention the balloon is to be so shaped as to dilate a shrunken intestine.
In Ichilian, the tube ends in a rounded discharge head or nozzle, that is not suitable for insertion into the shrunk end of an intestine.
In Ichilian, the tube is open to allow the passage of water therethrough and out through its perforated end. An open tube like that in Ichilian may enable contamination due to passage of fecal material through the tube to the operative field.
This structure, therefore, may not be suitable for internal surgery, where it is important to prevent contamination.
Ericson, U.S. Pat. 3,602,226, discloses a self-inflating catheter means to prevent loss of inflation fluid. The purpose of the invention is to improve the shelf life of the device. Another object is to provide a catheter with a removable sleeve or jacket. The jacket may be of a rigid material. It may be made of metal foil or a cohesive film.
The rigid jacket in Ericson is not the part that connects the reservoir and the expanding balloon. Rather, the jacket is only used to contain the inflated reservoir at the proximal end.
In Ericson, the tube that connects the reservoir and the inflatable distal end is apparently flexible. Its function indicates that it should be flexible--the device is inserted into an animal body, with the inflated sleeve within a chamber to be drained such as an animal bladder. To allow its insertion, the tube has to be flexible to adapt to the shape of the animal intestines.
For intestine surgery, it is important to use a rigid tube that will free one of the surgeon's hands, as detailed above. This feature is not provided in Ericson.
The device in Ericson has a main tubular arm with a hollow proximal connecting bell for receiving the drainage tubing connector end and a distal end with a drainage eye or eyes.
This structure may not achieve sterile conditions as required and critical in internal surgery, and may thus endanger the patient. The hollow tube may enable contamination due to passage of fecal material, as detailed above.
The tubular arm in Ericson has to be flexible to allow its insertion into an animal body up to the chamber to be drained. This structure, however, may not allow operation of the device with one of surgeon's hands, as detailed above.
Akiyama et al., U.S. Pat. No. 4,102,342, discloses a valved device used to plug an organic passage such as a person's nasal cavity. As illustrated there, the distal end of the device has no pointed end. Actually it has no solid end at all, rather it has an inflatable balloon.
The pipe in Akiyama that connects the balloon and the air pump is flexible, to adapt to the shape of an internal channel in the body.
As detailed there, the whole device, including the pipe, is made of an elastomer or rubber or an elastic material. Furthermore, a deformable pipe is detailed, that can correspond to the shape of the nasal cavity. Such a structure may not allow operation of the device with one of surgeon's hands.
The balloon in Akiyama cannot be inflated or deflated fast, as decided by the surgeon. Rather, the device in Akiyama has a valve that allows a gradual inflation of the balloon. This structure is devised to keep the balloon in place, while it stops a bleeding for example.
Such a structure is not suitable for the dilatation of an intestine, for several reasons. For example, it may take some time to inflate the balloon, whereas in an operation the surgeon requires a fast acting device to immediately dilate the intestine as required. The valve in Akiyama may prevent the surgeon from feeling the force on the intestine, that is important during a surgery. Moreover, to deflate the balloon the surgeon needs to activate the valve. This may take time and may distract the surgeon's attention during a critical operation. If an intestine is dilated for too long a time, it may be damaged.
MICHEAU P P A, Patent FR 2277566, discloses a catheter for surgical anastomosis, which is dilated after insertion to hold ends for sutures. The sheath of the catheter is slit longitudinally for a short distance, to produce three flexible strips. A steel wire is introduced through the central hole of the catheter, this wire having a ball fixed to its end.
After inserting the tube in the vessel to the point required, the wire is pulled. The ball contacts the end of the sheath and displaces it axially, causing the slit portion to expand and grip the vessel during the suturing process. If required, the free end of the catheter sheath is gripped in a syringe, leaving the wire free.
THIEDE A., Patent DE 4042248, discloses intestine section dilation forceps--has scale indicating valtrac ring size needed simultaneously. The forceps dilate a section of the intestine and simultaneously measure if for a Valtrac ring. Angular jaws dilate the section concerned to maximum to allow insertion of a bio-fragmentary ring, while the necessary ring size is simultaneously read off from a graduated scale. The jaws can be designed so that there is no injury during dilation, while the scale indicates the maximum ring size possible. USE--For intestinal anastomosis.
BOWMAN R. L., Patent WO 9416633, U.S. Pat. No. 5,437,638, details a multifinger topocatheter tip for angioplasty and manipulation--has inflatable tubes attached to lumen at distal end inverted by their respective lumens but can be erected, inflated, deflated etc. by application of fluid.
The catheter (1) has proximal and distal ends and internal lumens which extend between the proximal and distal ends. Adjacent inflatable tubes (6) are attached to The lumens at the distal end of the catheter. There are at least two lumens to which two inflatable tubes are attached and a central lumen for receiving a guide wire or optical fibre.
The lumens comprise between 3 to 13 including a central lumen and inflatable tubes comprises between 2 to 12. ADVANTAGE--Provides a method of dilating narrowed or constricted blood vessels, which recovers target objects, including embroli, from blood vessels.
SUMMERS D. P., U.S. Pat. No. 5,458,573, discloses a toposcopic dilation catheter for insertion into body passageway--has dilatation balloon lumen providing access to balloon carried at distal end of primary catheter shaft.
The toposcopic dilation catheter for insertion into a body passageway, comprises a catheter shaft for inserting into the body passageway, where the catheter shaft includes a distal end, an outer surface and an axial passage extending through it. There is a slide tube coaxially positioned within the axial passage, where the slide tube includes a distal end. There is an everting tube carried within the axial passage, and which has one end bonded to the distal end of the slide tube and the opposite end bonded to the distal end of the catheter shaft, where the everting tube may be everted under fluid pressure.
There is a first balloon carried on the outer surface of the catheter shaft. The balloon may be expanded under fluid pressure. There is a deflection wire extending along the length of the catheter shaft, where the catheter shaft includes a passageway for receiving the deflection wire through it. The deflection wire has a leading end connected to the distal end of the catheter shaft and connected to a thumb actuator at the opposite end of it for manipulating the distal end of the catheter shaft in an angular direction. It also has a second balloon mounted at the distal end of the slide tube, where the one end of the everting tube is bonded to the distal end of the slide tube rearward of the second balloon device. ADVANTAGE--Allows deep penetration of the vascular system even through narrow, totally or partially blocked blood vessels.
SAUNDERS R. J. et al., U.S. Pat. No. 5,525,388, discloses a dilatation balloon--has a constant wall thickness through its working and tapered sections, enabling it to collapse into a very small profile when subjected to a vacuum. A dilatation catheter (10) comprises an elongated shaft (11), a balloon (12) and an adapter (13) at the proximal end of the shaft (11). The shaft has an outer tubular member (14) and a concentric inner tubular member (15) having an inner lumen (16) adapted to receive a guide-wire (17). An annular lumen (18) between the inner (15) and outer (14) tubular members carries inflation fluid to the balloon (12).
The balloon (12) has a cylindrical working section (20) with tapered sections (21,22) at each end thereof terminating in skirt sections (23,24). The working section (20) and tapered sections (21,22) have the same wall thickness, but the skirts (23,24) do not. Skirt (24) is bonded to the distal end of the inner tube (15) whilst the skirt (23) is attached to the outer tubular section (14). The balloon (12) is formed from a parison (30) having a central tubular section (31) leading to parallel ends (34,35). When expanded during blowing the central section (31) forms the working section (20) of the balloon.
USE--Used for a variety of intra-luminal dilatations.
ADVANTAGE--Has constant wall thickness in both the working and tapered sections, enabling it to collapse when a vacuum is applied, into a very small transverse profile along its entire length.
BARRY R. J. et al., Patent WO 9523625, EP 748239, discloses a dilatation procedure for obstructed lumen in the body--uses catheter with cylindrical balloon which has tapering ends of different angles.
The dilatation procedure consists of using a catheter with an inflatable balloon (12) near its distal end. The balloon is generally cylindrical in shape when inflated with sloping proximal (24) and distal (28) ends, the first with a gradual slope and the second with an abrupt slope. During insertion the balloon is wrapped round the catheter (14) in a deflated state and inflated when in position in the obstructed region, and is deflated again and withdrawn after treatment. The balloon is made from a material including an inelastic polymer such as PET.
The angle of taper of its proximal end is about 10 deg., and that of its distal end is about 20 deg. ADVANTAGE--More convenient and atraumatic insertion and removal.
JENDERSEE B. A. et al., Patent WO 9200775, details a transluminal coronary angioplasty catheter with core wire--usable without alteration as fixed, semimovable or movable arrangement.
A catheter comprises a shaft with a main and a secondary lumen, and a balloon extension from the shaft distal end and having inner and outer members, the proximal end of the outer member being continuous with the main lumen and the member distal end forming the catheter distal tip. The outer member has a dilatation balloon formed in a part of its length.
The inner member is connected to the secondary lumen and its distal end terminates in an inflatable seal located within the catheter distal tip. The shaft is pref. of high-density polyethylene and is heat-bonded to the extension which is of linear low-density polyethylene. Pref. a tapered core wire of stainless steel or Ni--Ti alloy and coated with PTFE, silicon or hydrogel passes through the main lumen and outer member and terminates in a radiopaque metal coil.
ADVANTAGE--Can be used as an over-the-wire, fixed-wire or semi-movable wire catheter and changed from one to another at any time, and the seal allows selective fixing of a core wire or purging of air before use.
MATBURN HOLDINGS LTD (MATB-N), Patent DE 1925852, discloses a balloon catheter formed by tube and inflatable bag which are coated with a layer of SBR. GH-. Has two channels. The opening of one of the channels leading outside through the tube wall covered by an inflatable balloon, which is inflated by the entry of a metallised medium through the opening. Thus the tube and the balloon shell have a common external cover layer of SBR.
PUSTOVIT A. A. et al., Patent SU 1220669, discloses a surgical dilator--has perforation at lobe base, and thrust bush in working cavity, formed by lobes.
Perforation is designed in collet (1), at the base of the lobes of the proposed dilator. Thrust bush (3) is positioned in the working cavity, formed by the lobes, and moves along them.
The dilator is introduced into the lumen of a constricted pylorus. Thrust bush (3) is moved to the ends of the lobes by turning feed screw (4). The lobes are parted smoothly due to the screw transmission.
ADVANTAGE--Gives smooth dilation.
BICHOEV K H. et al., Patent RU 2069538, discloses a method for preparing patients for coloplasty following obstructive resection of large intestine--dilating distal end of large intestine daily for 19-23 days.
The procedure consists of carrying out eight dilation cycles of the large intestine daily for 19-23 days in the pre-operative period, each time injecting fluid in a volume equivalent to 110 per cent of that of the stump.
The fluid, an antiseptic solution introduced through the rectum, fills and stretches the stump of the large intestine, making further mobilisation unnecessary during the coloplasty operation, and allowing an end-to-end anastomosis to be formed with the rectum with no technical difficulties. Reduction in post-operative complications.
GRIGORYAN V. A. et al., Patent SU 1835267, technique for producing anastomosis during operations on upper urine canals--using dilatation of distal section of cut ureter by inserting hollow bougie to provide required clearance of distal section.
The proposed technique uses expanding an ureter distal section formed during resection of upper urine conduits. The clearance of ureter distal section is made equal to that of a proximal section by using hollow ureter dilators. As a result larger anastomosis is obtd., while rough structural and functional changes of upper urine canals are avoided.
USE/ADVANTAGE--In urology, for treating stenotic diseases of ureters. Reduced traumatisation and prevention of anastomosis stenosis.
BURLEIGH B. D. et al., Patent WO 9325265, discloses an angioplasty catheter--has dilation balloon on guide wire lumen within infusion lumen having balloon with infusion pores.
Angioplasty catheter (10) can also dispense therapeutic drugs, and comprises a dilation balloon (40) on a guidewire lumen (30) within an infusion lumen (20) carrying a balloon (50) which surrounds the dilation balloon (40) and has infusion pores (58) of size able to infuse insoluble or opt. soluble diagnostic agents, pref. up to 25 microns dia. Specifically pores (58) size range is 15-75 microns, or 15-50 microns, or 35-250 microns, or pres. dia. is 100 microns.
ADVANTAGE--Single catheter has dual function.
Prior art devices and procedures will now be described, to provide a background to the disclosure of the invention.
FIG. 1 details the shape of a resected intestine prior to anastomosis, as in prior art.
A gastro-intestinal operation including a resection may result in a first part of intestine 11, leading to anus, with intestine continuation to anus 14, and a second part of intestine. The subsequent anastomosis (suturing of the intestine segments) includes the suturing of first intestine end 12, to attach to second intestine end. The problem is the shrunk part 13 of first intestine. Bowel near cut area is shrunk because of the resection and a natural tendency of a cut intestine to shrink. The same effect results in the shrunk part of second intestine, near cut area 22.
The same operations are performed in the higher end of the intestine system, that is in the esophagus. There, the first part of intestine 11 leads to the patient's mouth rather than the anus. The operation may be performed in any part of the digestive system.
FIG. 2 illustrates an instrument and method of anastomosis using a circular stapling device as implemented in prior art.
The anastomosis instrument includes a base of instrument for anastomosis 31 using staples and a moving head of instrument for anastomosis 32, so that a gap 33 is formed between base 31 and head 32. A handle or connecting rod to handle 34 is used to handle and operate the device (firing the staples).
The instrument for anastomosis is inserted through intestine 11, so that first intestine end 12 is located just after the end of base 31, inside the gap 33 formed there.
A second part of intestine 21 is brought to the instrument so that it engulfs head 32 and its end 22 is also located in the gap 33.
The procedure as known in prior art involves bringing the ends 12, 22 of the intestines in the state as illustrated, then activating the anastomosis instrument so that head 32 is brought closer to base 31, to close the gap 33 and to bring the intestines ends 12, 22 into physical contact.
In this state, the instrument fires a plurality of staples in locations along the perimeter of head 32, to attach the intestine ends 12, 22 to each other. The anastomosis instrument is then removed, and the sutured intestine is left to recover.
A problem with this prior art procedure is that the intestine is shrunk near the recessed ends 12, 22 as illustrated in intestine regions 13, 23 which have a smaller diameter than the rest of the intestines 11, 21, due to a shrinkage tendency of resected bowels.
In a typical case, whereas the normal (prior to resection) diameter of intestines 11, 21 may be about 2 cm to 3.0 cm (centimeter), the diameter of shrunk intestines 13, 23 may be about 1 cm. This forces the surgeon to use a small diameter anastomosis instrument, since only such a narrow instrument of diameter about 2.5 cm can be inserted into the resected segment. The result is a small diameter anastomosis.
It is known that small diameter anastomosis, performed with a 2.5 cm diameter instrument, often leads to complications and to unsatisfactory recovery after the surgery.
Thus, surgeons would prefer to use a larger diameter instrument, for example a 2.8 cm or 3.1 cm or 3.5 cm diameter instrument. These instruments, however, cannot be inserted into the shrunk intestines, as explained above.
Anastomosis may be performed anywhere in the digestive system.
For example it may be performed in the lower end of the system (near the anus) or the higher end, that is in the esophagus. In the lower end there is room for repairs if there are post-surgery complications, since there is a long intestine which may be cut again and sutured. In the esophagus, however, there is no spare intestine, and there is no room for complications. Complications in an esophagus operation are very difficult to correct.
Therefore, in the esophagus it is still more important to perform a large diameter anastomosis. A 2.5 cm diameter anastomosis is definitely not recommended for operations of the esophagus.
Thus, for anastomosis in any location in the digestive system, the shrinkage tendency of the resected intestine may prevent the performance of a large diameter anastomosis as desired.